Kornimate/medical-research-clean huggingface dataset:
effect of hilotherm therapy on post-operative pain and swelling following surgical wisdom tooth removal

Conditions: Molar, Third; Wisdom Teeth

Summary: this study evaluates the efficacy of hilotherm therapy on the incidence of swelling and pain following the surgical removal of lower wisdom teeth. all participants will have two lower wisdom teeth removed, with the hilotherm cooling face mask only applied to one side of the patients' face for 60 minutes post-operatively, thus the patient being their own control.

how does hilotherm therapy affect post-operative pain and swelling after surgical wisdom tooth removal? wisdom tooth removal is one of the most common minor oral surgical procedures. the most widely experienced post-operative complications include pain and swelling, and so any research into how these effects can be minimised is of utmost importance to improve the quality of care we can deliver to our patients. our research is investigating the efficacy of hilotherm therapy, which uses pre-shaped plastic facial masks through which water circulates at a controlled temperature, to reduce the experience of post-operative pain and swelling. the hilotherm face mask will be placed immediately after the surgery, while the patient is in the recovery area and will be worn on one side of the face, this being randomised using a computer programme and decided at the time of surgery. it will be worn for one hour after wisdom tooth removal. we will then use 3d photography analysis of the patients face to assess the extent of swelling, their assessment of pain using a visual analogue scale, and their overall satisfaction with hilotherm therapy. these measurements will be recorded at: day 0 - 60 minutes post-op after patient has worn hilotherm cooling mask day 3 day 10 day 24 the person analysing the 3d images will be blinded to the side of the intervention. all patients undergoing wisdom tooth removal on both sides, of similar surgical difficulty, to be carried out under a general anaesthetic of the daycase unit of one hospital will be eligible. both extractions will be carried out by the same surgeon. participants who undergo complications during or after the procedure will be excluded from our study. extractions which end up being too dissimilar will also be excluded, and patients unsuitable for use of the hilotherm mask (for example allergies) will also not be considered. any patients with immune system affecting diseases, and patients who suffer allergic reactions to pharmaceutical agents will also not be considered. no other elements of treatment will be changed from normal protocol.

Eligibility criteria:
inclusion criteria: * any patients requiring bilateral lower third molars extracted of similar technical difficulty under general anaesthesia exclusion criteria: * any intra-operative complications * any post-operative complications, including infection * if the extractions end up being too dissimilar surgically * any contra-indication to the hilotherm mask * patients with any immune system-affecting diseases * patients with allergies to pharmaceutical drugs (eg. analgesics or antibiotics)
study in patients with onychomycosis treated with mycoclear® and ciclopirox

Conditions: Onychomycosis of Toenails

Summary: the goal of this study is to learn about the effectiveness and safety of two products, ciclopirox or mycoclear®, in treating fungal infections. people with fungal infections of the nails and over the age of 18 were treated at the department of dermatology, irccs azienda ospedaliero - universitaria sant'orsola in bologna (italy) between january 1, 2019, and april 30, 2023. the people were treated as part of their regular medical care with ciclopirox or mycoclear®. in this observational study, the data are now being reviewed to answer the following questions: • does mycoclear® work as well as ciclopirox for fungal nail infections, when used for up to 24 weeks? people were seen at the beginning for an initial assessment, and then again at two, four, 12, and 24 weeks. the doctor did the following main tests during the study period: * performing the clinical evaluation * checking the lab test for a fungal infection. * measuring how much of the nail grows without problems. the results of this study will help dermatologists choose the best treatment for fungal nail infections.

in italy the prevalence of onychomycosis in subjects aged \>65 years was as high as 35%. this observational, retrospective study has the objective to evaluate the safety and effectiveness of two treatment for distal and lateral subungual onychomycosis (dlso), the most prevalent clinical variant of onychomycosis. two cohorts of patients treated between january 2019, and april 2023 are involved: 40 patients treated with mycoclear, a medical device that is widely used as an antifungal in outpatient clinical practice and 40 patients treated with ciclopirox, an commonly used antifungal drug. the primary outcomes are the investigator global assessment of efficacy, mycological assessment, and the extent of healthy nail growth. safety is evaluated by the incidence of adverse events. patients were treated for a maximum period of 24 weeks, in accordance with the "standard usual care" of the center and were visited at baseline, week two, four, 12, and 24 (final visit).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * patients clinically and microscopically koh diagnosed with distal and lateral subungual onychomycosis (dlso) (≤30% involvement of the nail plate of at least one of the great toenails) and evaluated as mild to moderate following osi6. * patients presenting positive direct potassium hydroxide (koh) microscopy and positive fungal culture for dermatophytes exclusion criteria: * other types of onychomycoses. * subjects who used systemic antifungal agents within 6 months or topical antifungal agents on toenails within 6 weeks of screening. * pregnant woman, lactating woman.

Keywords: onychomycosis medical device observational study
intra-pemetrexed plus third-generation small molecule tki drugs (e.g. 'osimertinib') versus third-generation small molecule tki drugs alone for leptomeningeal metastasis from epidermal growth factor receptor mutation-positive non-small-cell lung cancer

Conditions: Leptomeningeal Metastasis

Summary: intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (nsclc). since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from nsclc. it has been recommended as the preferred drug for intrathecal chemotherapy by the chinese society of clinical oncology (csco) guidelines. tyrosine kinase inhibitors (tkis) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (egfr) mutations. due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. an international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from nsclc with egfr exon 19 deletion or exon 21 l858r/t790m mutation. it makes tkis the mainstay of treatment for patients with egfr-mutant nsclc with leptomeningeal metastases. however, whether third-generation small molecule tki drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with lm from egfr- mutant nsclc remains undetermined.

the aim of this study is to compare the effects of intra-pemetrexed plus third-generation small molecule tki drugs (e.g. 'osimertinib') versus third-generation small molecule tki drugs alone in leptomeningeal metastasis from egfr mutation positive nsclc.

Eligibility criteria:
inclusion criteria: 1. male or female aged between 18 and 75 years. 2. histologically or cytologically confirmed diagnosis of nsclc with single activating egfr mutations (l858r or exon19del). 3. confirmed diagnosis of leptomeningeal metastasis according to esmo/eano guidelines. 4. normal liver and kidney function; wbc≥4000/mm3, plt≥100000/mm3. 5. no history of severe nervous system disease. 6. no severe dyscrasia. exclusion criteria: 1. any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and glasgow coma score less than 11. 2. any evidence of extensive and lethal progressive systemic diseases without effective treatment. 3. patients with poor compliance or other reasons that were unsuitable for this study.

Keywords: leptomeningeal metastasis intrathecal chemotherapy pemetrexed third-generation small molecule tki drugs osimertinib epidermal growth factor receptor mutation
deplipido study: functional and lipidomic analysis of plasma hdl in patients with depression compared to controls

Conditions: Depression

Summary: depression is a disabling condition in terms of psychosocial alteration and also in terms of physical comorbidities. depression doubles the risk of myocardial infarction compared with the general population, and this cardiovascular comorbidity leads to an increase in mortality in patients suffering from depression, even exceeding suicide-related mortality. it is therefore important to better understand the mechanisms linking depression and cardiovascular disease. among the hypotheses that may account for the increased cardiovascular risk in patients with depression, lipid abnormalities are likely to play a crucial role. thus, qualitative and functional abnormalities in hdl lipoproteins are an important line of research, insofar as these lipid abnormalities have been recognized as important atherogenic abnormalities in populations at high cardiovascular risk, which is the case of patients with depression. in this clinical, epidemiological and scientific context, a collaborative study undertaken by both the department of psychiatry of the dijon bourgogne university hospital of and the inserm lnc-umr 1231 (padys) laboratory of the university of bourgogne franche-comte is an original translational research project, and the first study to perform a lipidomic analysis of hdl, coupled with a functional analysis of these lipoproteins in depression.


Eligibility criteria:
inclusion criteria: * for patients with recurrent depression : * patient who has provided oral consent * adult with moderate to severe depression according to dsm-5 criteria (hamilton hdrs-17 score ≥ 18), with a number of depressive episodes ≥ 3 * patients presenting with a first depressive episode * patient who has provided oral consent * adult with moderate to severe characterized depression according to dsm-5 criteria (hamilton hdrs-17 scale score ≥ 18) presenting with a first depressive episode. * controls * person who has provided oral consent * adult who has never shown signs of depression exclusion criteria: * person not affiliated with national health insurance * person subject to a measure of legal protection (curatorship, guardianship) * pregnant or breastfeeding women * adult unable to express consent * minors * person with a metabolic syndrome (according to ncep/atp-iii criteria: 3 of the following 5 criteria: waist circumference ≥ 102 cm in males and ≥ 88cm in females, triglycerides \> 1.50 g/l, hdl-cholesterol \< 0.40 g/l in h, hdl-cholesterol \< 0.50 g/l in f, blood pressure ≥130/85mmhg, fasting blood glucose ≥ 1.10 g/l), * person with type 1 or type 2 diabetes, * person with a mild depressive episode (hdrs-17\<18), * person with concomitant antipsychotic treatment * person with bipolar disorder, * person with a moderate to severe alcohol use disorder according to dsm-5 criteria * person with schizophrenia, * person with a persistent delusional disorder, * person with an autism spectrum disorder.
clinical effects of brain machine interface in chronic stroke patient

Conditions: Stroke

Summary: determination of clinical effects of brain machine interface in chronic stroke patient without wrist extensor strength

the purpose of this study is to compare recoverix with individual eeg calibration and without individual eeg calibration to determine the clinical effect of brain machine interface in chronic stroke patient without wrist extensor strength

Eligibility criteria:
inclusion criteria: * hemiplegic patients secondary to first cerebrovascular accidents * weak wrist extension * onset ≥ 6 months * fugl-meyer assessment score ≥ 19 * cognitively intact enough to understand and follow the instructions from the investigator exclusion criteria: * wrist extensor spasticity above or modified ashworth scale 2 * severe upper extremity pain that could interfere with rehabilitation therapy * neurological disorders other than stroke that can cause motor deficits * uncontrolled severe medical conditions.

Keywords: brain machine interface chronic stroke wrist extensor strength
effects of oral protein load on kidney function in patients undergoing cardiac surgery

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) occurs in approximately one-third of patients undergoing cardiac surgery (cs), and represents one of the most significant negative predictors of patient outcome in this population. in the healthy adult, a high protein meal is known to enhance glomerular filtration rate and is mediated by an increase in renal blood flow. the investigators hypothesized that preoperative oral protein load may precondition the kidneys for upcoming insults and reduce the rate of postoperative aki and long-term renal outcome.

acute kidney injury (aki) occurs in approximately one-third of patients undergoing cardiac surgery (cs), and represents one of the most significant negative predictors of patient outcome in this population. to date, there is no therapy to prevent aki. in the healthy adult, a high protein meal is known to enhance glomerular filtration rate (gfr) and is mediated by an increase in renal blood flow. the investigators hypothesized that preoperative oral protein load may induce an adaptive response of the kidneys, and precondition the kidneys for upcoming insults. in the present study, the investigators aimed to compare the prevalence and severity of aki in patients undergoing oral high protein load of the 'preoperative renal functional reserve predict risk of aki after cardiac operation' study to age- and gender-matched "controls" who had a standard preoperative care the day prior to surgery within the same period (november 2014-october 2015) at san bortolo hospital, vicenza, italy. both groups were followed 1 year post-discharge to evaluate long-term renal outcomes.

Eligibility criteria:
inclusion criteria: 1. subjects older than 18 years undergoing elective cardiac surgery 2. subjects older than 18 years with an estimated egfr \>60 ml/min/1.73 m2 (ckd-epi) 3. subjects who signed informed consent forms exclusion criteria: 1. pregnancy 2. chronic kidney disease ≥ stage iii (kdigo criteria) 3. preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days) 4. solitary kidney 5. diabetes mellitus type 1 6. recent cardiac arrest or myocardial infarction up to 7 days before surgery 7. liver failure or cirrhosis 8. total parenteral nutrition 9. haemoglobin \<11 g/dl 10. sepsis 11. history of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency 12. transplant donor or recipient 13. active autoimmune disease with renal involvement 14. rhabdomyolysis 15. prostate hypertrophy with international prostate symptom score ≥20 16. transcatheter aortic valve implantation 17. active neoplasm 18. patients who did not pause angiotensin-converting enzyme inhibitors or angiotensin ii receptor blockers or received non-steroidal anti-inflammatory drugs a minimum of 48 hours before hospital admission. 19. patients who received intravenous radiocontrast agents within the 72 hours before hospital admission.
study of 90y-dota-hll2 as a consolidation therapy after r-chop in patients with diffuse large b-cell lymphoma

Conditions: B-cell Lymphoma

Summary: phase ii, multi-centric, open-label, study. disseminated diffuse large b-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90y-dota-hll2 as a consolidation therapy after first line of chemotherapy.

initial treatment: 6 courses of chop-r 14 with evaluation of response before c4 (observation of no change or progression at this time will get the patient off study). consolidation : fractionated rit (8 weeks after the end of r-chop: 2 injections of 15 mci/m2 of 90y-dota-hll2 and hll2 at day 1 and day 8).

Eligibility criteria:
inclusion criteria: * age \> 60 and \< 80 years * non eligible for stem cell transplantation * cd20 diffuse large b-cell lymphoma according to the who classification * bulky stage i and ii \> ou =7 cm and stage iii and iv * performance status 0 - 2 * creatinine clearance \>ou = 50 ml/min (cockroft formula). * serum bilirubin \< ou =30 mmol/l * leucocytes \> ou =3 g/l, granulocytes \> ou = 1,5 g/l, platelets \>ou= 100 g/l. * hiv negative * written informed consent exclusion criteria: * age \ 80 years * other types of lymphomas except cd20+ diffuse large b-cell lymphoma according to the who classification * histologic transformation of low grade lymphoma (involvement of the bone marrow by small b-cell lymphoma will not lead to exclusion of the patient) * primary lymphoma of the central nervous system and transformed gastro intestinal malt lymphoma * meningeal involvement * bone marrow involvement \> 25% after r-chop * aggressive post-transplantation lymphoma * absence of cd20 expression on tumor cells * non bulky stages i et ii * hiv positive * active hepatitis b or c * left ventricular ejection fraction \< 50%. * contra-indication to r-chop treatment * previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * participation at the same time in another study in which investigational drugs are used * absence of written informed consent

Keywords: disseminated diffuse large b-cell lymphoma first line treatment r chop 90y-dota-hll2 patients older than 60 years
extracellular vesicles from mesenchymal cells in the treatment of acute respiratory failure

Conditions: Severe Acute Respiratory Syndrome (SARS); Acute Respiratory Distress Syndrome (ARDS); Pneumonia

Summary: this is a phase i/ii, randomized, double-blind, placebo-controlled clinical trial that will evaluate the safety and potential efficacy of therapy with extracellular vesicles (evs) obtained from mesenchymal stromal cells (mscs), patients with moderate to severe acute respiratory distress syndrome due to covid-19 or other etiology. participants will be allocated to receive evs obtained from mscs or placebo (equal volume of plasma-lyte a). blinding will cover the participants, the multidisciplinary intensive care team and the investigators.

the studied population will consist of 15 patients diagnosed with acute respiratory failure syndrome admitted to the intensive care unit of hospital são rafael. this research aims to assess the safety and potential effectiveness of intravenous therapy using extracellular vesicles derived from mesenchymal cells in patients with moderate to severe acute respiratory distress syndrome. the treatment group will receive intravenous administration of extracellular vesicles obtained from mesenchymal cells, while the control group will receive a placebo. ev group: will consist of 10 participants who will receive two infusions of 25 ml of the investigational product (plasma-lyte a solution containing evs obtained from mscs), intravenously, at intervals of 48 h. placebo group: will consist of 5 participants who will receive an equal volume of plasma-lyte a, intravenously, following the same schedule as the iv group: two infusions with an interval of 48 hours.

Eligibility criteria:
inclusion criteria: * age \>= 18 years old; * chest ct radiological image with ground-glass opacities or chest x-ray with - bilateral infiltrates characteristic of pulmonary edema; * in invasive mechanical ventilation with peep 5 cm h2o and pao2/fio2\<250mmhg; * respiratory failure not explained by cardiac causes or fluid overload. exclusion criteria: * unable to provide informed consent; * pregnancy or breastfeeding; * patients with active malignancy who have received chemotherapy in the last 2 years; * life expectancy of less than 6 months or in exclusive palliative care; * severe liver failure, with a child-pugh score \> 12; * previous renal failure: patients already undergoing dialysis or patients with gfr \< 30ml/min/1.73 m2 * clinical or radiological suspicion of tuberculosis; * chronic respiratory failure; * use of ecmo; * moribund (high probability of death within the next 48 hours).

Keywords: sars-cov-2 intravenous therapy extracellular vesicles ards mesenchymal cells
treatment of acute pancreatitis with ketorolac

Conditions: Acute Pancreatitis

Summary: patients with acute pancreatitis will be randomly assigned in either study group to receive oral (injection) ketorolac or the control group. in patients who cannot tolerate oral medications, ketorolac injection will be used.

patients with acute pancreatitis will be randomly assigned in either study group or control group. * the study group will receive injection or oral ketorolac. * the control group will receive standard medical treatment. ketorolac is administrated three times daily by mouth or injection starting from the time of admission for the first three days of hospitalization (72 hours). hs-crp will be measured in admission in addition to standard laboratory tests.it will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. patients will follow up for organ failure involvement and duration of hospitalization. the study will continue to gather clinical follow up information up to four months.

Eligibility criteria:
inclusion criteria: 1. predicted severe acute pancreatitis 2. enrollment within 72 hours of diagnosis 3. obtaining informed consent 4. age \>18 years exclusion criteria: 1. heart disease, hypertension 2. hemorrhagic diathesis, incomplete hemostasis, high risk of bleeding 3. lactating women 4. pregnancy 5. advanced renal disease 6. hypersensitivity to ketorolac, aspirin, other nsaids 7. concurrent use with aspirin, other nsaids, probenecid, or pentoxifylline 8. active or history of peptic ulcer disease 9. recent or history of gi bleeding or perforation 10. inflammatory bowel disease 11. severe hepatic impairment or active hepatic disease

Keywords: inflammation
enbrel liquid immunogenicity protocol

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the antibody formation to enbrel liquid in subjects with rheumatoid arthritis

the purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant mtx therapy. the rate of neutralizing antibodies to liquid etanercept will also be assessed.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * must be able to self-inject or have someone who can do so for them * should have rheumatoid arthritis per ara criteria and screening lab results per predefined value exclusion criteria: * any prior biologic therapy for inflammatory disease * any prior cyclophosphamide therapy * not using adequate contraception * pregnant or breast-feeding or any significant concurrent medical condition

Keywords: rheumatoid arthritis, enbrel liquid, antibodies